INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER
FDA premarket approval P020025/S074 · decided 2015-06-23
Approval details
- PMA number
- P020025
- Supplement
- S074
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2015-06-12
- Decision date
- 2015-06-23
- Days to decision
- 11 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR CLARIFICATIONS TO THE ELECTRICAL CONNECTION SEQUENCE IN THE DIRECTIONS FOR USE (DFU).
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